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RayzeBio is seeking an experienced Director of Regulatory Affairs - CMC, who will oversee CMC regulatory functions for radiopharmaceutical therapies. The role emphasizes leadership, strategic regulatory planning, and strong collaboration within a dynamic biotech environment.
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Job Summary
This role involves developing and executing the global regulatory strategy for radiopharmaceutical drugs to secure successful approvals from Health Authorities.
The position requires leading multifunctional teams to manage technology transfer, change controls, and critical reviews of CMC documentation for regulatory compliance.
Candidates will benefit from a comprehensive compensation package including competitive salary ranges, stock opportunities, and extensive health and wellbeing benefits.
Matching Summary
Match Score: 75
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RayzeBio is seeking an experienced Director of Regulatory Affairs - CMC, who will oversee CMC regulatory functions for radiopharmaceutical therapies. The role emphasizes leadership, strategic regulatory planning, and strong collaboration within a dynamic biotech environment.
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Salary
Base: $210,572 - $255,164 (Remote US) / $227,418 - $275,577 (San Diego CA); Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellness programs
Skills & Requirements
Must-have
Radiopharmaceutical therapy experience required
Authoring IND IMPD NDA MAA DMF sections
CMC global regulatory strategy development
Health Authority meeting leadership
Quality Module content management
Nice-to-have
Strong cross-functional collaboration skills
Adaptability in dynamic start-up environment
Experience with radiochemistry innovation
Proactive professional ethics and integrity
Key Requirements
Bachelor's degree in chemistry or related field
7+ years hands-on regulatory experience with Master's degree
5+ years hands-on regulatory experience with advanced degree
Prior experience with radiopharmaceutical therapy or PET drug products
Independent authoring of IND IMPD NDA MAA DMF CMC sections